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Gradia® 400006

by Gc America Inc. 2 variants

Gradia® 400006 is a Class I device made by Gc America Inc., listed in FDA GUDID since 10 Feb 2017 (UDI-DI D6584000061), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD6584000061 UDI-DI Date10 Feb 2017ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Gradia®
Generic name
Root canal post, preformed
Model / Ref / Catalog
400006
Primary DI / UDI-DI
D6584000061
FDA product code
ELR
GMDN term
Root canal post, preformed
Device class
Class I
Regulation number
872.3810
GUDID distribution status
In Commercial Distribution

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Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (11, all answered No)